skinny.

Latest / Medical Device made Easy Podcast

What are the surprises during MDR & IVDR transition? [Erik Vollebregt]

There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take care of this.

Is there a possibility that we are moving to a model similar to the FDA?

Then another important piece of information came from SNITEM & BVMed. Both are asking for an extension of the EU MDR transition from May 2024 to May 2026.

Why and would this be considered by the EU Commission?

Let’s ask our preferred lawyer Erik Vollebregt. And I am sure this will help you understand all concepts for EU MDR and IVDR

Who is Erik Vollebregt

Erik…

The skinny

The skinny isn't ready yet — notes appear once the transcript is processed.